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PRIMARY FUNCTION • Associate Director/Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects, • Serves as a team member supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, medical monitors, regulatory authorities, medical affairs, commercial, Key Opinion Leaders, Advisory Boards, • The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, drug-drug interactions, PBPK, PopPK modeling and E-R analysis. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions MAJOR RESPONSIBILITIES AND DUTIES • Accountable and responsible for the Clinical Pharmacology support for the HUTCHMED global portfolio, • Provide scientific insights that drive global clinical development decisions and support global regulatory submissions, • Responsible for ensuring appropriate Clinical Pharmacology representation on drug/ dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project, • The incumbent will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed, • Responsible for ensuring planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting), • Responsible for ensuring leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies, • Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first in human studies and dosage regimens in patients, • Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs, • During the pre-clinical stages of drug development, works with Drug Discovery team to ensure that sufficient preclinical PK/PD knowledge exists to support progression into first in man studies, • Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies, • Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the Clinical Pharmacology study, • Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators etc., • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the Clinical and Development teams and in regulatory documentation such as labeling, • Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design, • Participates in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management, • Acts as technical lead for specific development projects, Phase I/III and Clinical Pharmacology centric studies, • Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders MINIMUM REQUIREMENTS • PhD in clinical pharmacology, quantitative pharmacology, pharmacokinetics, or related field / MD/ PharmD preferred, • Biologics including monoclonal antibody, bispecific antibody, and antibody-drug conjugate experience is preferred, • Experiences in Oncology/Autoimmune disease field is preferred, • Proven expertise in pharmaceutical/biotech industry (8-15 years) with adequate knowledge in ICH guidelines, Good Clinical Practice applicable to Clinical Pharmacology, • Direct experience with clinical pharmacology summary documents required for Regulatory submissions, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization, • Experience in clinical development and new drug registration, • Mastery of statistics applied to clinical research, • Ability to work with pharmacometrician for PopPK modeling, E-R analysis, PBPK, and PK-PD modeling, and interpret the data to support the clinical development, • Good ability to interpret complex clinical data and experimental results, • Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy, • Self-motivated and self-disciplined individual with superb problem-solving and leadership skills, • Excellent English (writing and speaking) and excellent mastery of English medical terminology PREFERRED SKILLS AND EXPERIENCE: • Knowledge of FDA, EMA and ICH guidelines and regulations, • Record of successful publications in the area of clinical pharmacology/pharmacometrics, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required, • Candidate must demonstrate thorough understanding of principles of clinical pharmacology including clinical study design, analysis, and interpretation, and application of these approaches to drug development, guidelines in the design of clinical trials and development plans KEY COMPETENCIES: • Ability to organize and work simultaneously on multiple projects, • Ability to work in a matrix, project-oriented environment, • Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment, • Supports the success of a group being led by providing clarity, support and tools needed to excel as things change, • Maintains a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the organization, • Actively builds relationships and networks with others across and beyond HUTCHMED working constructively across organizational boundaries despite differences in interests, perspectives and need

The Senior Workday Analyst performs a key role in leading the operational functions of Workday as well as continually optimizing our HR technology solutions. This position will collaborate with HR Leadership to establish and maintain the HR Technology roadmap, provide expertise, project management, maintenance, testing, and training of Workday and HR Technology solutions. This position will serve as a technical point-of-contact for assigned functional area and assist with ensuring data integrity, build downstream system integrations, reporting and execute process improvements. The rate is between $50 to $60 an hour. Your Responsibilities: · Maintain Workday HCM day-to-day ensuring proper and accurate data integrity, performance and security. · Provide system support, training and documentation for all end users. · Maintain expert knowledge of the HCM, Security, Reporting Workday modules · Manage Workday updates, integrations and repairs, partnering with IT, vendors and other SMEs as needed · Generate and deliver Workday reports and dashboards for end users and auditors · Analyze data to identify company and system trends, making recommendations to Leadership for process and system improvements; identify opportunities for automation to increase efficiencies. · Implement, manage and report on security protocols ensuring compliance · Manage relationships with system vendors and service providers, evaluating performance and negotiating contracts Qualifications: · Bachelor's degree in Information Systems, Computer Science or related field required · 5-7 years of Workday experience, preferably in a global setting · 7-9 years of overall professional experience · Experience with one or more of the following technologies: Workday webservice, PeopleSoft, Core Connectors, EIB/DTS, Workday Report Writer, SOAP requests · Workday Certifications preferred

Monitor and report on service levels, turnaround times, and customer feedback. Create reports to track underwriting performance and efficiency. Create reports to track sales performance and efficiency.

Comply with all applicable laws and regulations; (2) Recruit and evaluate job applicants and candidates for employment; (3) Conduct background checks; (4) Manage your employment relationship with us, including for: (a) onboarding processes; (b) timekeeping, payroll, and expense report administration

This role requires expertise in Tableau for creating reports and dashboards, proficiency in SQL Server for data extraction and query management, and the ability to support various databases and systems. Develop and maintain regular and ad-hoc reports for Service, Underwriting, Sales. Develop reports

Our client in Avenel, NJ is looking for an On-site Data Entry Clerk for a direct hire position.Must be able to work in office 5 days a week.At least 2 years of Data Entry experience.Must be ok with assisting in answering phones and helping other departments.Prior Import experience a plus.Benefits: H

Monitor and report on service levels, turnaround times, and customer feedback. Create reports to track underwriting performance and efficiency. Create reports to track sales performance and efficiency.

Administrative Assistant/Intake Coordinator.Career TEAM is a leading workforce development organization on a mission to transform lives.We blend cutting-edge technology with compassionate, high-touch services to drive real, measurable outcomes in the lives of job seekers across the country.At Career

Full Time Administrative Assistant.MHA promotes mental health and total wellness for individuals facing challenges associated with mental illness and addiction recovery.We increase community awareness while enhancing mental well-being through advocacy, education, prevention, treatment, and services.

Administrative Assistant/Receptionist - ABA Center - RBT/BT Experience.Union, NJ, USA Hourly $20-$24 per hour.Do you have experience as a BT/RBT and are looking for a role that is more administrative? If so, this role may be for you!.Flywheel Centers is dedicated to providing high-quality ABA therap

Business Analyst for Accu Reference Medical Lab, LLC.Develop business strategies; maintain project documentation; research market trends and manage data to support daily operations.Medical, dental & vision health insurance, 401k plan & PTO.To apply, email resume to Nicolas.

Work From Home Data Entry Clerk.We are looking for people who are motivated to participate in paid research across the country and local areas.Join This Work from Home USA Market Research Panel Today.You have two options when it comes to paid research: you can either take part in person or online.Th

Work at Home Data Entry Clerk - Part Time.We are looking for people who are motivated to participate in paid research across the country and local areas.Join This Work from Home USA Market Research Panel Today.You have two options when it comes to paid research: you can either take part in person or

Insight Global is seeking a Business Analyst to support Merck Animal Health in driving data-informed decision-making across digital transformation and operational initiatives.This role will work closely with cross-functional teams in veterinary science, supply chain, and IT to deliver actionable ins

Utility Industry Business Analyst.We are primarily looking for a strong Utility Industry Business Analyst with prior work experience in a Gas & Electric Transmission and Distribution utility in the Energy Efficiency and CIS areas.Proven experience in strategic business analysis roles.Proficiency in

Create and prepare reports and dashboards to track contract performance metrics and industry financial benchmarks. Assist with internal budget development and variance analysis, including quarterly and annual reporting cycles. Evaluate and improve internal controls, financial workflows, and reportin

Job Role: Erp System Implementation Support.This role will support the implementation of a new ERP system across multiple cell therapy facilities in northern New Jersey.The site data lead will immerse themselves within these sites and with global functions to complete data cleansing, build standardi

Drive positioning strategy to increase ADP's placement in market evaluations, reports, and client-influencing assessments. As an Analyst Relations Executive, you will lead ADP's industry analyst relations program across the HCM portfolio, reporting to the Vice President of Solutions Marketing.

Organize meetings with Regulatory Operations users to gather these requirements to support the reporting of new products or to remediate existing reporting errors and omissions. The role involves working on multiple complex projects in parallel to successfully deliver solutions for the Regulatory Re

Senior Business Analyst - Cybersecurity Service Delivery Team.Calling all innovators - find your future at Fiserv.We're Fiserv, a global leader in Fintech and payments, and we move money and information in a way that moves the world.We connect financial institutions, corporations, merchants and cons

Job Classification: Operations - Insurance Operations.A GLOBAL FIRM WITH A DIVERSE & INCLUSIVE CULTURE.As the Global Asset Management business of Prudential, we're always looking for ways to improve financial services.We're passionate about making a meaningful impact - touching the lives of millions

This role reports directly to the GM/owner and is responsible for the organization and coordination of office operations, procedures, and resources to facilitate organizational effectiveness and efficiency.

Prepare, compose and initiate accurate and timely correspondence, memoranda, presentation material and reports. Process and/or prepare expenses reports for senior management. Demonstrated ability to compose, edit and proofread written documents (routine letters, business correspondence and reports o

Prepare and coordinate reports and engineering submission packages.

Make routine travel arrangements and complete expense reports.

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Business Analyst (Non-It): III (Senior).Assignment Type: ~7-month contract.Location: 100 Connell Drive Berkeley Heights New Jersey.Summary of Position: Need assistance with Accel Network only customer disputes related to card not present transactions.

Do you love helping people through difficult situations? Then, don't miss your chance to join our Franchise as a new Administrative Assistant.In this position you will be making a difference each and every day.We have a sincere drive towards the goal of helping make fire and water damage "Like it ne

The Administrative Assistant will perform data entry, maintain various database systems, prepare and maintain physical files, and create written reports to brief management as well as cross-reference data to ensure validity and accuracy in preparation of reports. Maintain attendance reports; leave r

Responsible for accident/incident reporting.

Administrative And Project Assistant.Cali School of Music seeks a dynamic, highly organized Administrative and Project Assistant to support the Director of the School and help coordinate our innovative Immersive Residency Program.This flexible, part-time temporary position is ideal for someone with

Aptitude for understanding financial reports and extracting information. Assist with general office administrative tasks such as ordering and maintaining inventory of office supplies and equipment, preparation of customer complaint responses, keep vehicle titles and auto insurance current, draft doc

Compose and/or edit letters, memos, reports, procedures, etc.

Create reports for time, labor, overtime, and comp time tracking.

Perform data entry, maintain spreadsheets and develop reports (e.

The Administrative Assistant will perform data entry, maintain various database systems, prepare and maintain physical files, and create written reports to brief management as well as cross-reference data to ensure validity and accuracy in preparation of reports. The Administrative Assistant is resp

The Administrative Assistant will be responsible for providing administrative support to the Refugee Support Services program, which includes but is not limited to the following duties:.Assisting Intake Coordinator and Case Workers with client communication.Assisting clients with document production

PRIMARY PURPOSE: To provide administrative support including preparing correspondence and reports, filing and other general office support activities. Reports, and other documentation; files documents, maintains and tracks suspense file, photocopies, sends and receives facsimile transmissions, etc.

This role requires expertise in Tableau for creating reports and dashboards, proficiency in SQL Server for data extraction and query management, and the ability to support various databases and systems. Collect, analyze, and interpret data from various sources to generate reports and dashboards. Dev

As a Virtual Administrative Assistant, you will be responsible for providing remote administrative support, including: provide administrative support remotely.Duties and responsibilities can change depending on business needs.

Demonstrated ability to compose, edit and proofread written documents (routine letters, business correspondence and reports of varying complexity). Skilled in the creation of spreadsheets, reports, charts, and graphs.

Be part of our success story as a American Airlines Data Entry Clerk to respond promptly to inquiries and resolve basic issues, follow safety procedures and company policies, and manage daily responsibilities with a focus on quality and efficiency.Other duties include provide excellent service to cu

Performs more complex administrative activities including managing projects, composing letters and reports, preparing/editing presentations, and recommendations.

Business Analyst Job Duties: Elicits, analyzes, specifies, and validates the business needs of stakeholders, be they customers or end users.Collaborates with project sponsors to determine project s

We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of each model.In this role you will need to hold an expert level of financial reasoning- a completed or

Top skills needed: Outlook, Concur, Event Planning.Roles and Responsibilities: Under the direction of supervisors, assistant will be responsible for providing administrative support, as well as general clerical/secretarial support to the team.Ability to act as a team player, strong interpersonal ski

We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of each model.In this role you will need to hold an expert level of financial reasoning- a completed or

Take the next step in your career as our new Netflix Data Analyst to perform responsibilities as a Data Analyst.Work with your team to maintain efficiency and high standards.Deliver outstanding service to customers and colleagues.Perks include competitive pay, flexible scheduling, training opportuni